Kornimate/medical-research-clean huggingface dataset:
r-bmd in refractory or relapsed lymphoma, geltamo clinical trial

Conditions: Non-Hodgkin's Lymphoma

Summary: assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with follicular lymphoma.

assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with follicular lymphoma who are refractory or in relapse.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years. 2. patients with follicular lymphoma grade 1, 2 or 3a, cd20 +, histologically confirmed lymph node biopsy or tissue. be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle llc, and nhl. 3. follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy). 4. ecog ≤ 2. 5. signed written informed consent. exclusion criteria: 1. clinical suspicion or documentation of histological transformation. 2. have received prior chemotherapy scheme, first line without rituximab. 3. prior autologous or allogeneic. 4. cns infiltration by lf (primary cns lymphoma or lymphomatous meningitis). 5. past or active hepatitis b (at least one of the following markers hbsag, hbe ag, anti-hbc, hbv dna) 6. hcv infection. hiv infection or other conditions of serious immunosuppression. 7. previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. 8. cardiac function in cardiac patient known or prior treatment with anthracyclines with ef \<50%. 9. impaired renal function (creatinine\> 1.5 x upper limit of normal, lsn) or a creatinine clearance \<50 ml / h, not related to lymphoma. 10. impaired liver function (bilirubin, ast / alt or ggt\> 2 x uln) were not related to lymphoma. 11. women who are nursing or pregnant. women of childbearing potential will be included prior pregnancy test serum / urine negative. use effective contraception to be kept for 1 year after cessation of rituximab. 12. patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. 13. severe acute or chronic infection in activity. 14. any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

Keywords: follicular non-hodgkin's lymphoma relapse refractory
liver-pilp first-in-man

Conditions: Liver Metastases

Summary: the purpose of this study is to determine whether the pilp-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.

the objective of this medical device study, is to demonstrate the feasibility of the liver pilp intervention. the liver pilp intervention will be considered feasible if the procedure is demonstrated to be safe and the liver pilp kit performs according to specifications.

Eligibility criteria:
inclusion criteria: 1. subjects with ecog (eastern cooperative oncology group) stages 0 or 1 2. unresectable metastatic disease predominant in the liver exclusion criteria: 1. more than 60 % tumor involved liver tissue 2. abnormal vascular anatomy 3. severe atherosclerosis 4. dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries 5. short suprahepatic vena cava segment (\< 1.5 cm) 6. one or both jugular veins are occluded 7. other severe, concomitant diseases regarding the subject status

Keywords: liver percutaneous isolated localized perfusion pilp isolated hepatic perfusion ihp liver metastases unresectable liver metastases of different etiologies
combination chemotherapy and thalidomide in treating patients with stage i, stage ii, or stage iii multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. thalidomide may stop the growth of cancer by stopping blood flow to the tumor. combining chemotherapy with thalidomide may kill more cancer cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage i, stage ii, or stage iii multiple myeloma.

objectives: * determine the overall response rate in patients with newly diagnosed stage i, ii, or iii multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide. * determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen. outline: this is an open-label, nonrandomized study. patients receive vincristine iv and doxorubicin iv continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. patients also receive low-dose oral thalidomide daily on days 1-28. treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression. patients are followed until disease progression or bone marrow transplantation. projected accrual: approximately 17-37 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * newly diagnosed stage i, ii, or iii multiple myeloma (mm) * no refractory or relapsed mm patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * not specified hematopoietic * not specified hepatic * bilirubin less than 1.5 mg/dl * ast less than 2.5 times upper limit of normal renal * not specified other * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation * no active serious infections uncontrolled by antibiotics * no insufficient mental capacity that would preclude informed consent * no other medical condition or reason that would preclude study participation * willing and able to comply with the fda-mandated s.t.e.p.s program prior concurrent therapy: biologic therapy * no prior thalidomide chemotherapy * no more than 1 course of prior vincristine, doxorubicin, and dexamethasone endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * no concurrent alcohol consumption

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
the exposition study

Conditions: Multiple Sclerosis, Relapsing-Remitting; Environmental Exposure; Lifestyle Factors

Summary: this is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with multiple sclerosis (pwms).the objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwms, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin d levels and medical history. specifically, the variation of micrornas is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. following the functional exposome approach:(1)information on a pwms sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) on the same pwms sample, the internal exposome variation will be measured. microrna levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. at the same time, cytokines and neurofilament proteins (nfl) will be measured as biomarkers of neurodegeneration and axonal damage. adults (≥ 18 years) pwms, with relapsing-remitting course, diagnosis of ms according to 2017 mcdonald criteria and residing in pavia or milan (italy) will be included. potentially eligible pwms will be screened by a neurologist expert in ms who will verify that all the inclusion criteria will be fulfilled. to validate variation among 7 selected ms diagnostic mirna, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (δct) for each mirna will be considered as the outcome measure. two hundred eligible pwms who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.


Eligibility criteria:
inclusion criteria: * we will include persons with multiple sclerosis (pwms) attending the centro sclerosi multipla of the irccs fondazione c. mondino of pavia, according to the following inclusion criteria: * age ≥ 18 years * diagnosis of ms according to 2017 mcdonald criteria * relapsing-remitting course (rr) * routine clinical examinations scheduled in the study period september 15, 2023, to march 15, 2024, * residing in the provinces of pavia and milano * informed consent form signed exclusion criteria: * exclusion criteria will involve people refusing to participate in the study or people not completely meet the inclusion criteria. potentially eligible pwms will be screened by a neurologist expert in ms who will verify that all the inclusion criteria will be fulfilled.

Keywords: multiple sclerosis exposome microrna cytokines microbiome neurofilament air pollution urbanization lifestyle nutrition physical activity inflammation
the safety and efficacy of n-acetyl cysteine in children with drug-resistant epilepsy

Conditions: Drug Resistant Epilepsy

Summary: this study aims at investigating the possible efficacy and safety of n-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy

n-acetyl-cysteine (nac), a glutathione precursor, is proven to activate the nuclear factor e2-related factor 2( nrf2) in mouse models of status epilepticus, thus inhibiting high mobility group box 1 (hmgb1) cytoplasmic translocation in the hippocampal neural and glial cells and preventing the linkage between oxidative stress and neuroinflammation for which the redox-sensitive protein hmgb1 is central. therefore,it may be useful as an adjuvant in treating various medical conditions, especially neuropsychiatry.

Eligibility criteria:
inclusion criteria: * patients aged 3-18 years with intractable childhood-onset epilepsy. * all patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ilae definition. * the subject is willing and able to comply with the study requirements exclusion criteria: * any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a gfr \< 60 ml/min/1.73 m2 or electrolyte imbalance. * patients with known allergy to n-acetyl cysteine. * patients taking antioxidant and/or anti-inflammatory medications

Keywords: n-acetyl cysteine
optimal index for pediatric distal forearm fractures

Conditions: Pediatric Distal Forearm Fractures

Summary: this is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.the patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.


Eligibility criteria:
inclusion criteria: 1. males or females 3 to 12 years old. 2. any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting. exclusion criteria: 1. children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with kirschner wires. 2. children whose casts is split will be excluded.

Keywords: optimal index for pediatric distal forearm fractures
safety and comfort of al-4943a ophthalmic solution

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

in this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Eligibility criteria:
inclusion criteria: * able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits. * negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. * other protocol-defined inclusion criteria may apply. exclusion criteria: * history or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease. * history of any clinically significant external ocular disease within 30 days of the start of the study. * presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes. * other protocol-defined exclusion criteria may apply.

Keywords: ocular discomfort al-4943a ophthalmic solution
a study of avastin (bevacizumab) in combination with mfolfox6 in treatment-naïve patients with metastatic colorectal cancer with or without k-ras mutations, and comparison to cetuximab

Conditions: Colorectal Cancer

Summary: this randomized, open-label study will evaluate the safety and efficacy of avastin (bevacizumab) added to standard mfolfox6 chemotherapy in treatment-naïve patients with stage iv metastatic colorectal cancer. according to k-ras gene mutation status, patients will be assigned or randomized to receive either avastin 5 mg/kg intravenously (iv) on day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on day 1 followed by 250 mg/m2 iv every week, in addition to mfolfox6 every 2 weeks. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * histologically confirmed adenocarcinoma of the colon or rectum * stage iv metastatic disease with at least one measurable metastatic lesion according to recist criteria * tumour tissue sample available for assessment of k-ras and braf genes * prior radiotherapy must have been completed 4 weeks before randomization * adequate bone marrow, kidney and liver function * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * previous chemotherapy for metastatic disease * completion of adjuvant treatment for colorectal cancer (stage i, ii and iii) in the 12 months preceding randomization * prior treatment with bevacizumab, cetuximab or other egfr inhibitors * clinical or radiographic evidence of brain metastases * clinically significant cardiovascular disease or disorder * history of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours * hiv, hepatitis b or c infection
preventing bacterial and viral infections among injection drug users

Conditions: Bacterial Infection; HIV

Summary: we propose a randomized controlled trial (rct) of the skin intervention, compared to an assessment-only condition (both groups receive rapid hiv testing, a review of testing results, and brief hiv prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at boston medical center. in the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. we hypothesize that the skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission * have injected heroin, cocaine, or meth for at least three months * positive urine screen for heroin, cocaine, or meth exclusion criteria: * currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal * cannot provide informed consent * not able to complete interviews in english (expected to exclude \<5% of idus) * in police custody, expecting incarceration * unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes * plan to move out of the boston area in the next 12 months.

Keywords: injection drug use
postoperative complications of orthopedic surgery in patients from high-altitude regions

Conditions: Orthopedic Surgery; Postoperative Complications; High Altitude

Summary: this study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. the ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.

prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. this elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. this study will focus on orthopedic surgery patients from high-altitude regions. using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. additionally, perioperative data such as electronic medical records, laboratory test results, ecg waveforms, echocardiography, chest ct images, and other pertinent records will be also collected. through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. asa classification i-iii; 3. patients who have lived at an altitude above 2500 meters for more than 6 months ; 4. patients scheduled for elective orthopedic surgery. exclusion criteria: 1. urgent or emergent surgery; 2. expected hospital stay \< 48 hours; 3. inability to provide informed consent； 4. patients who have been out of high-altitude regions for over three months.

Keywords: high-altitude population perioperative cohort orthopedic surgery
comparison of biolimus a9 and everolimus drug-eluting stents in patients with st segment elevation myocardial infarction

Conditions: Coronary Heart Disease; Percutaneous Coronary Intervention

Summary: the primary objective of this study is: * comparison of a safety and effectiveness of third generation des (biolimus a9 and everolimus) in patients with stemi treated by primary pci with oct guidance. a rate of 9 month mace (deaths, myocardial infarction, ischemia driven tlr) will be assessed in both groups. the secondary outcomes are a comparison of (using oct): * number of uncovered stent struts * number of malapposed stents struts * in-stent neointimal volume * in-segment assessment of vessel wall response to des

the aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation des (biolimus a9 and everolimus) in patients with evolving stemi with the oct guidance (to optimize a stent implantation) a serial oct analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. furthermore, the in-segment vessel wall response to des implantation will also be analysed. the goal is to enroll 400 patients (200 in each group) with oct guidance in 100 patients in each group.

Eligibility criteria:
inclusion criteria: 1. acute stemi within 12 hours from symptoms onset 2. native coronary disease with a lesion suitable for stenting 3. vessel size in between 2.5-3.75mm 4. patient is willing to provide written informed consent 5. male or female patients between 18-85 years of age exclusion criteria: 1. significant left main disease 2. killip class iv 3. known allergy to aspirin and or clopidogrel/ticlopidine 4. recent bleeding (\<1month) 5. patient in anticoagulant therapy 6. no suitable coronary anatomy for oct scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/) 7. pregnancy 8. severe liver or renal disease (cr\>2.0) 9. life expectancy \< 1 year

Keywords: stents
high-intensity interval training for older adults

Conditions: Age-Related Sarcopenia

Summary: this study will examine differences in a 12 week high-intensity interval training regimen. the total body hiit program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. the specific objectives focus on examining cardiovascular endurance, neuromuscular function, and muscle architecture.


Eligibility criteria:
inclusion criteria: * 65-95 years of age or older * physical independent (barthel index) * physician clearance to participate * no medication changes in previous 30 days * no structured resistance training program in previous 6 months exclusion criteria: * contraindications to high-intensity exercise39 (par-q questionnaire) * severe mental impairment (\<18 on montreal cognitive assessment) * neurodegenerative or acute neurological diagnoses (e.g., parkinson's disease, stroke, traumatic brain injury)

Keywords: geriatrics high-intensity interval training rehabilitation